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Clonidine for Neurocognitive Sequelae

Primary Purpose

Treatment-Related Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clonidine
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-Related Cancer focused on measuring Cancer, Clonidine, Neurocognitive sequelae

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a prior diagnosis of a pediatric malignancy (brain tumors, solid tumors, leukemia/lymphoma) who are in remission, and are > 3 years from initial diagnosis. Patients must have completed therapy a minimum of 6 months prior to study entry. Patients must have English as their primary language Patients must be >3 and less than or equal to 16 at the time of study enrollment Patients must fulfill the operational criteria for neurocognitive deficit and have an IQ > 50. Patients must be currently enrolled in a school or a learning environment where an adult familiar with the child's academic performance can provide ratings of that performance over the time of the trial. Patients must have wbc, hemoglobin and platelet parameters which fall within the norms for the patient's age. Patients must have adequate hepatic function (bilirubin less than or equal to 1.5 mg/dl and SGPT < 5x normal) and renal function (normal Cr for age/GFR greater than or equal to 70 ml/min/1.73m2) Patients must be able to swallow gel caps. Signed informed consent must be obtained according to institutional guidelines. When appropriate the patient will be included in all discussion in order to obtain verbal assent. Protocol and informed consent must be approved by the local IRB prior to any patient registration and reapproved every 12 months. Exclusion Criteria: Patients who have evidence of a significant neurological abnormality prior to their cancer diagnosis that would affect neuro-behavioral development (such as genetic: Fragile X, Downs syndrome, or acquired disorders: closed head injury) Patients with a prior (pre-cancer) diagnosis of attention deficit hyperactivity disorder or major depression Patients who have a medical condition which would preclude the use of clonidine (medicated for hypertension, cardiac conduction disturbances, cerebrovascular disease, or chronic renal failure) Patients must not have received psychotropic medication (SSRIs, methylphenidate), anxiolytics, or hypnotics within 2 weeks of study entry. Patients who are receiving concurrent scheduled barbiturates or sedating drugs. Currently (within 6 months) known to abuse drugs or to be dependent on any drug including alcohol or with a positive urine drug screen. Women of childbearing age must not be pregnant or lactating. This group is excluded because of teratogenic potential of this agent demonstrated in rat and rabbit models.

Sites / Locations

  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
January 10, 2013
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00166686
Brief Title
Clonidine for Neurocognitive Sequelae
Official Title
Clonidine for the Treatment of Neurocognitive Sequelae Following Cancer Treatment in Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never initiated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hopes to determine the long-term effect of clonidine on children's academic and psychosocial function.
Detailed Description
The long term prognosis for many children diagnosed with brain tumors and other malignancies has improved dramatically over the last decades and is expected to continue to rise as a result of improved treatment. The increased survival in pediatric oncology, however, has been associated with an increased recognition of neurobehavioral sequelae of cancer and its treatment. Current understanding of the incidence, pathogenesis, and natural history of these neurobehavioral abnormalities is limited and considerable individual variation in the presence and severity of these complications has been noted. Central nervous system (CNS) abnormalities associated with childhood cancer and its treatment have been demonstrated on at least three levels which may be interrelated: neurobehavioral abnormalities, brain imaging abnormalities, and neurotransmitter abnormalities. Patients will be randomized to either clonidine or placebo. Study medication will be administered in a double blind fashion beginning with a four-week dose titration period followed by a four-week maintenance period. Total duration of dosing is 18 weeks. Patients who derive a benefit from clonidine administration may continue for an additional 30 weeks of therapy. PK samples will be collected at weeks 9 and 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-Related Cancer
Keywords
Cancer, Clonidine, Neurocognitive sequelae

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clonidine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a prior diagnosis of a pediatric malignancy (brain tumors, solid tumors, leukemia/lymphoma) who are in remission, and are > 3 years from initial diagnosis. Patients must have completed therapy a minimum of 6 months prior to study entry. Patients must have English as their primary language Patients must be >3 and less than or equal to 16 at the time of study enrollment Patients must fulfill the operational criteria for neurocognitive deficit and have an IQ > 50. Patients must be currently enrolled in a school or a learning environment where an adult familiar with the child's academic performance can provide ratings of that performance over the time of the trial. Patients must have wbc, hemoglobin and platelet parameters which fall within the norms for the patient's age. Patients must have adequate hepatic function (bilirubin less than or equal to 1.5 mg/dl and SGPT < 5x normal) and renal function (normal Cr for age/GFR greater than or equal to 70 ml/min/1.73m2) Patients must be able to swallow gel caps. Signed informed consent must be obtained according to institutional guidelines. When appropriate the patient will be included in all discussion in order to obtain verbal assent. Protocol and informed consent must be approved by the local IRB prior to any patient registration and reapproved every 12 months. Exclusion Criteria: Patients who have evidence of a significant neurological abnormality prior to their cancer diagnosis that would affect neuro-behavioral development (such as genetic: Fragile X, Downs syndrome, or acquired disorders: closed head injury) Patients with a prior (pre-cancer) diagnosis of attention deficit hyperactivity disorder or major depression Patients who have a medical condition which would preclude the use of clonidine (medicated for hypertension, cardiac conduction disturbances, cerebrovascular disease, or chronic renal failure) Patients must not have received psychotropic medication (SSRIs, methylphenidate), anxiolytics, or hypnotics within 2 weeks of study entry. Patients who are receiving concurrent scheduled barbiturates or sedating drugs. Currently (within 6 months) known to abuse drugs or to be dependent on any drug including alcohol or with a positive urine drug screen. Women of childbearing age must not be pregnant or lactating. This group is excluded because of teratogenic potential of this agent demonstrated in rat and rabbit models.
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Clonidine for Neurocognitive Sequelae

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